DETAILED ACTION
This Office Action is in response to the filing of amendments to the claims filed 10/06/2025, due to a restriction requirement. As per the amendments, claims 10-13 have been cancelled, and no claims have been amended or added. Thus, claims 1-9 are pending in the application.
Notice of Pre-AIA or AIA Status
The present application, filed on or after March 16, 2013, is being examined under the first inventor to file provisions of the AIA .
Election/Restrictions
Applicant’s election without traverse of claims 1-9 in the reply filed on 10/06/2025 is acknowledged.
Drawings
The drawings are objected to because Figs. 4(a)-5(d) fail to comply with 37 CFR 1.84(b)(1) whereby drawings must not be photographs unless that is the only practicable medium for illustrating the invention.
Corrected drawing sheets in compliance with 37 CFR 1.121(d) are required in reply to the Office action to avoid abandonment of the application. Any amended replacement drawing sheet should include all of the figures appearing on the immediate prior version of the sheet, even if only one figure is being amended. The figure or figure number of an amended drawing should not be labeled as “amended.” If a drawing figure is to be canceled, the appropriate figure must be removed from the replacement sheet, and where necessary, the remaining figures must be renumbered and appropriate changes made to the brief description of the several views of the drawings for consistency. Additional replacement sheets may be necessary to show the renumbering of the remaining figures. Each drawing sheet submitted after the filing date of an application must be labeled in the top margin as either “Replacement Sheet” or “New Sheet” pursuant to 37 CFR 1.121(d). If the changes are not accepted by the examiner, the applicant will be notified and informed of any required corrective action in the next Office action. The objection to the drawings will not be held in abeyance.
Specification
Applicant is reminded of the proper language and format for an abstract of the disclosure.
The abstract should be in narrative form and generally limited to a single paragraph on a separate sheet within the range of 50 to 150 words in length. The abstract should describe the disclosure sufficiently to assist readers in deciding whether there is a need for consulting the full patent text for details.
The language should be clear and concise and should not repeat information given in the title. It should avoid using phrases which can be implied, such as, “The disclosure concerns,” “The disclosure defined by this invention,” “The disclosure describes,” etc. In addition, the form and legal phraseology often used in patent claims, such as “means” and “said,” should be avoided.
The abstract of the disclosure is objected to because it includes the implied phrases “In general terms the present invention proposes” in line 1 and “Also disclosed is” in line 3 which should be removed. Applicant is reminded that removal of these phrases should still result in an abstract of at least 50 words in length. A corrected abstract of the disclosure is required and must be presented on a separate sheet, apart from any other text. See MPEP § 608.01(b).
Claim Objections
Claim 5 is objected to because of the following informalities: the term “the external surface” should be changed to read --an external surface-- in order to have proper antecedent basis. Appropriate correction is required.
Claim Rejections - 35 USC § 112
The following is a quotation of 35 U.S.C. 112(b):
(b) CONCLUSION.—The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the inventor or a joint inventor regards as the invention.
The following is a quotation of 35 U.S.C. 112 (pre-AIA ), second paragraph:
The specification shall conclude with one or more claims particularly pointing out and distinctly claiming the subject matter which the applicant regards as his invention.
Claims 1-9 are rejected under 35 U.S.C. 112(b) or 35 U.S.C. 112 (pre-AIA ), second paragraph, as being indefinite for failing to particularly point out and distinctly claim the subject matter which the inventor or a joint inventor (or for applications subject to pre-AIA 35 U.S.C. 112, the applicant), regards as the invention.
Claims 1, and 4-6 lack a transitional phrase, making the metes and bounds of the claim limitations unclear, and making it unclear whether or not the claim is to be interpreted as open-ended or close-ended.
Claim 1 appears to be claiming an apparatus claim “A nozzle holder for securing a nozzle in an inhalation device” in line 1. However, the only following limitation of “the nozzle holder being obtained or obtainable by metal injection moulding (MIM)” appears to be a process or method step. Hence, there is no claimed structure for the nozzle holder, and it is further unclear whether or not the claim is intended to be an apparatus or method claim.
A broad range or limitation together with a narrow range or limitation that falls within the broad range or limitation (in the same claim) may be considered indefinite if the resulting claim does not clearly set forth the metes and bounds of the patent protection desired. See MPEP § 2173.05(c). In the present instance:
Claim 7 recites the broad recitation “a non-rotationally symmetric recess” in line 1, and the claim also recites “optionally an oblong, elliptical, or oval shaped recess” in line 2, which is the narrower statement of the range/limitation.
Claim 8 recites the broad recitation “comprising steel” in line 1, and the claim also recites “optionally stainless steel” in line 1 which is the narrower statement of the range/limitation.
The claim(s) are considered indefinite because there is a question or doubt as to whether the feature introduced by such narrower language is (a) merely exemplary of the remainder of the claim, and therefore not required, or (b) a required feature of the claims.
Any remaining claims are rejected for being dependent on a rejected claim.
Claim Rejections - 35 USC § 103
The following is a quotation of the appropriate paragraphs of 35 U.S.C. 102 that form the basis for the rejections under this section made in this Office action:
A person shall be entitled to a patent unless –
(a)(1) the claimed invention was patented, described in a printed publication, or in public use, on sale, or otherwise available to the public before the effective filing date of the claimed invention.
(a)(2) the claimed invention was described in a patent issued under section 151, or in an application for patent published or deemed published under section 122(b), in which the patent or application, as the case may be, names another inventor and was effectively filed before the effective filing date of the claimed invention.
The following is a quotation of 35 U.S.C. 103 which forms the basis for all obviousness rejections set forth in this Office action:
A patent for a claimed invention may not be obtained, notwithstanding that the claimed invention is not identically disclosed as set forth in section 102, if the differences between the claimed invention and the prior art are such that the claimed invention as a whole would have been obvious before the effective filing date of the claimed invention to a person having ordinary skill in the art to which the claimed invention pertains. Patentability shall not be negated by the manner in which the invention was made.
Claims 1 and 3-9 are rejected under 35 U.S.C. 102(a)(1) as anticipated by or, in the alternative, under 35 U.S.C. 103 as obvious over Säll et al. (US Pub. 2022/0001402) in view of Sivigny et el. (US Pub. 2010/0300437).
Regarding claim 1, Säll discloses a nozzle holder for securing a nozzle in an inhalation device (see Figs. 2-4 where aerosol unit 10 fits over and is secured onto the distal end of chamber 110 that is a nozzle), the nozzle holder being obtainable by metal injection moulding (MIM)(this is a product by-process limitation, whereby the specific method of making the nozzle holder is not by itself a patentable distinction, provided the end product is the same or obvious from a prior art product. Hence, the nozzle holder of Säll is capable of being obtainable by MIM (see [0060] where the use of injection moulding with metal is used for a component of the nozzle holder, and where a person of ordinary skill in the art would, as a design consideration, be able to choose a process such as MIM for the creation of the nozzle holder), which results in the same nozzle holder).
In the alternative that the nozzle holder of Säll is not obtainable by metal injection moulding, then Sivigny teaches an inhalation device and its components, where parts of the device can be made by metal injection moulding (see [0008] and [0022]-[0023]).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the method by which the nozzle holder of Säll is made to be made by metal injection moulding as taught by Sivigny, as it would be a simple substitution of one well-known manufacturing method for another well-known manufacturing method, to yield the predictable result of manufacturing the nozzle holder. Additionally, the use of metal injection moulding is understood to be useful for creating components that come into contact with pressurized fluids or have complex geometries (Sivigny; see [0023]).
Regarding claim 3, the modified Säll device has an exterior surface having a surface roughness average (Ra) of 0.56 microns or more (Sivigny; see [0033] where the surface texture creates from the particles in the MIM have a roughness of around 1 micron).
Regarding claim 4, the modified Säll device has wherein the exterior surface of the nozzle holder has a non-periodic surface texture (Sivigny; see [0033]-[0034] where it is understood that the surface texture of the moulding component has a roughness, which is random, at least in the microscopic scale. Further, as the modified Säll device is made from the same process as the claimed invention, it stands that the resultant surface texture is the same).
Regarding claim 5, the modified Säll device has wherein 40% or more of the external surface of the nozzle holder is pocketed (Säll; see Fig. 3 where the open space in the middle of aerosol unit 10, circumferentially bound by axially oriented body 20, is a pocket of the nozzle holder that is clearly at least 40% of the external surface).
Regarding claim 6, the modified Säll device has being non-rotationally symmetric (Säll; see Fig. 3 where an axis of symmetry can be drawn across the top of the aerosol unit 10 to form non-rotational symmetry).
Regarding claim 7, the modified Säll device has a non-rotationally symmetric recess (Säll; see Fig. 3 where the cavity space in the center of aerosol unit 10 has an axis of symmetry that is non-rotationally symmetric).
Regarding claim 8, the modified Säll device comprises steel, optionally stainless steel (Säll; see [0060] and see Sivigny [0032]).
Regarding claim 9, the modified Säll device has an inhalation device comprising a nozzle holder according to claim 1 (Säll; see Fig. 2 where aerosol dispenser 1000 has the aerosol unit 10).
Claim 2 is rejected under 35 U.S.C. 103 as being unpatentable over Säll in view of Sivigny as applied to claim 1 above, and further in view of Johansson et al (US Pub 2016/0184484).
Regarding claim 2, the modified Säll device has an exterior surface having a water contact angle (some material property of the material). It is understood that the water contact angle is a material property of the nozzle holder due to the material it is made of. The modified Säll device is made of steel (Säll; see [0060] and Sivigny [0012], [0032]), which is understood to have a water contact angle of about 60 degrees as an inherent material property.
The modified Säll device lacks a detailed description of an exterior surface having a water contact angle equal to or less than 60°.
However, Johansson teaches a nozzle and tube for liquid delivery in a medical application, where a surface is hydrophilic so as to have a water contact angle of about 60 degrees (see [0029] where the surface has a substrate surface that can be made of steel, and designed to be hydrophilic such that the water contact angle is 60 degrees or less).
Therefore it would have been obvious to one of ordinary skill in the art before the effective filing date of the claimed invention to modify the water contact angle of the modified Säll device to have a water contact angle of about 60 degrees as taught by Johansson, as it would provide hydrophilic surface for the aqueous solution at a known water contact angle. Further, it is a specified material property of steel, and thus the steel surface of the modified Säll device is understood to be hydrophilic.
Conclusion
The prior art made of record and not relied upon is considered pertinent to applicant's disclosure: Kim et al. (US Pat. 9,345,847), Hausmann et al. (US Pat. 9,192,734), Geser et al. (US Pat. 7,681,811), and Wachtel (US Pat. 9,265,910).
Any inquiry concerning this communication or earlier communications from the examiner should be directed to MATTHEW D ZIEGLER whose telephone number is (571)272-3349. The examiner can normally be reached Mon-Thurs 9:00-6:00.
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If attempts to reach the examiner by telephone are unsuccessful, the examiner’s supervisor, Justine Yu can be reached at (571)272-4835. The fax phone number for the organization where this application or proceeding is assigned is 571-273-8300.
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/MATTHEW D ZIEGLER/Examiner, Art Unit 3785
/JUSTINE R YU/Supervisory Patent Examiner, Art Unit 3785